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NCT00956007 · OUTCOME

Percentage of Participants Alive (Overall Survival) by Ethnicity

RT With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer · Source last updated 2026-01-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.

What was measured

NIH-required analysis. Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Analysis occurred after all participants had potentially been on study for at least 5 years. The distributions of survival times are compared, which is reported in the statistical analysis results. Five-year rates are provided.

Analysis population: Randomized eligible participants. Data were stratified by ethnicity.

Groups in this outcome

IMRT

Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).

IMRT Plus Cetuximab

Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks). Cetuximab: 400 mg/m\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
IMRT287
IMRT Plus Cetuximab290

Reported measurements

Hispanic or Latino

Analysis denominator · Participants

GroupSource count
IMRT22
IMRT Plus Cetuximab16
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT81.8Not reported65.797.9Not reported
IMRT Plus Cetuximab80.0Not reported59.8100Not reported
Not Hispanic or Latino

Analysis denominator · Participants

GroupSource count
IMRT256
IMRT Plus Cetuximab268
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT66.9Not reported60.972.9Not reported
IMRT Plus Cetuximab76.2Not reported70.981.5Not reported
Unknown or Not Reported

Analysis denominator · Participants

GroupSource count
IMRT9
IMRT Plus Cetuximab6
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMRT88.9Not reported68.4100Not reported
IMRT Plus Cetuximab83.3Not reported53.5100Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        65.7
        upper Limit
        97.9
        value
        81.8
      2. group Id
        OG001
        lower Limit
        59.8
        upper Limit
        100
        value
        80.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        16
      units
      Participants
    title
    Hispanic or Latino
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        60.9
        upper Limit
        72.9
        value
        66.9
      2. group Id
        OG001
        lower Limit
        70.9
        upper Limit
        81.5
        value
        76.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        256
      2. group Id
        OG001
        value
        268
      units
      Participants
    title
    Not Hispanic or Latino
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        68.4
        upper Limit
        100
        value
        88.9
      2. group Id
        OG001
        lower Limit
        53.5
        upper Limit
        100
        value
        83.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Unknown or Not Reported
denoms
  1. counts
    1. group Id
      OG000
      value
      287
    2. group Id
      OG001
      value
      290
    units
    Participants
description
NIH-required analysis. Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Analysis occurred after all participants had potentially been on study for at least 5 years. The distributions of survival times are compared, which is reported in the statistical analysis results. Five-year rates are provided.
dispersion Type
95% Confidence Interval
groups
  1. description
    Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
    id
    OG000
    title
    IMRT
  2. description
    Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks). Cetuximab: 400 mg/m\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.
    id
    OG001
    title
    IMRT Plus Cetuximab
param Type
NUMBER
population Description
Randomized eligible participants. Data were stratified by ethnicity.
reporting Status
POSTED
time Frame
From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
title
Percentage of Participants Alive (Overall Survival) by Ethnicity
type
OTHER_PRE_SPECIFIED
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice